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NIH Collaboratory
Living Textbook of
Pragmatic Clinical Trials

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Rethinking Clinical Trials

A Living Textbook of Pragmatic Clinical Trials

  • Design
    • What is a Pragmatic Clinical Trial?
    • Decentralized Pragmatic Clinical Trials
    • Developing a Compelling Grant Application
    • Experimental Designs and Randomization Schemes
    • Endpoints and Outcomes
    • Analysis Plan
    • Using Electronic Health Record Data
    • Building Partnerships and Teams to Ensure a Successful Trial
    • Intervention Delivery and Complexity
    • Patient Engagement
  • Data, Tools & Conduct
    • Assessing Feasibility
    • Acquiring Real-World Data
    • Assessing Fitness-for-Use of Real-World Data
    • Study Startup
    • Participant Recruitment
    • Monitoring Intervention Fidelity and Adaptations
    • Patient-Reported Outcomes
    • Clinical Decision Support
    • Mobile Health
    • Electronic Health Records–Based Phenotyping
    • Navigating the Unknown
  • Dissemination & Implementation
    • Data Sharing and Embedded Research
    • Dissemination Approaches for Different Audiences
    • Implementation
    • End-of-Trial Decision-Making
  • Ethics & Regulatory
    • Privacy Considerations
    • Identifying Those Engaged in Research
    • Collateral Findings
    • Consent, Disclosure, and Non-Disclosure
    • Data and Safety Monitoring
    • Ethical Considerations of Data Sharing in Pragmatic Clinical Trials
    • Ethics for AI and ML
    • IRB Responsibilities and Procedures

Key Considerations for PCTs – ARCHIVED

CHAPTER SECTIONS

ARCHIVED PAGE

Archived on July 31, 2025. Go to the latest version.

ARCHIVED – What is a Pragmatic Clinical Trial

Section 6

Key Considerations for PCTs – ARCHIVED

Expand Contributors

Kevin Weinfurt, PhD

Contributing Editors

Karen Staman, MS
Jonathan McCall, MS
Liz Wing, MA

Planning an ePCT often requires different approaches to study design, stakeholder engagement, start-up, data collection, data analysis, ethical oversight, and dissemination than do traditional RCTs (O’Rourke et al. 2015). To provide expertise and support to the NIH Collaboratory Trials, several working groups, or Cores, were established to assist study teams as they navigate from planning to implementation. The webpage for each Core listed below provides information and links to multiple resources including webinars, publications, and white papers that reflect the knowledge, insight, and best practices acquired by the Cores in collaboration with the NIH Collaboratory Trials.

  • Electronic Health Records
  • Patient-Centered Outcomes
  • Health Care Systems Interactions
  • Ethics and Regulatory
  • Biostatistics and Study design

Previous Section Next Section

SECTIONS

CHAPTER SECTIONS
sections

  1. Why Are We Talking About Pragmatic Trials? – ARCHIVED
  2. The Embedded Pragmatic Clinical Trial Ecosystem – ARCHIVED
  3. Differentiating Between RCTs, PCTs, and Quality Improvement Activities – ARCHIVED
  4. Pragmatic Elements: An Introduction to PRECIS-2- ARCHIVED
  5. PRECIS-2 Case Study – ARCHIVED
  6. Key Considerations for PCTs – ARCHIVED
  7. Additional Resources – ARCHIVED

REFERENCES

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O’Rourke PP, Carrithers J, Patrick-Lake B, et al. 2015. Harmonization and streamlining of research oversight for pragmatic clinical trials. Clin Trials. 12:449–456. doi:10.1177/1740774515597685. PMID: 26374678.

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Version History

May 15, 2020: Made nonsubstantive changes to the listing of the Collaboratory’s Core Working Groups as part of the annual content update (changes made by L. Wing).

Published August 25, 2017

current section :

Key Considerations for PCTs – ARCHIVED

  1. Why Are We Talking About Pragmatic Trials? – ARCHIVED
  2. The Embedded Pragmatic Clinical Trial Ecosystem – ARCHIVED
  3. Differentiating Between RCTs, PCTs, and Quality Improvement Activities – ARCHIVED
  4. Pragmatic Elements: An Introduction to PRECIS-2- ARCHIVED
  5. PRECIS-2 Case Study – ARCHIVED
  6. Key Considerations for PCTs – ARCHIVED
  7. Additional Resources – ARCHIVED

Citation:

Weinfurt K. ARCHIVED – What is a Pragmatic Clinical Trial: Key Considerations for PCTs – ARCHIVED. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/archived-what-is-a-pragmatic-clinical-trial/key-considerations-for-pcts/. Updated September 25, 2025. DOI: 10.28929/093.

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